Trial Outcomes & Findings for Effect of Citrate Dialysate on Vascular Calcification (NCT NCT04956120)
NCT ID: NCT04956120
Last Updated: 2026-05-05
Results Overview
Rate of progression of breast arterial calcification (BAC) is calculated by linear regression of 3 mammograms over one year in each treatment arm (Months 0, 6 and 12 versus Months 12, 18 and 24). Progression of calcification is quantified as the length of calcified artery segments per year, measured in millimeters. Slower progression of vascular calcification, indicated by lower values, is a desirable outcome.
COMPLETED
NA
54 participants
3 measurements during 12 months of treatment for each study period (up to 24 months for both years of the study)
2026-05-05
Participant Flow
The first individual gave informed consent to participate on May 27, 2021 and all study follow up was complete by March 18, 2025. Participants were enrolled from Emory Dialysis centers in Atlanta and Decatur, Georgia, USA.
Participant milestones
| Measure |
Citrate Dialysate Then Standard Dialysate
Participants receiving hemodialysis using a citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a non-citrate acid concentrate dialysate (standard dialysate) for the second year of the study.
Citrate Dialysate: Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. When used, citrate is provided in the acid concentrate. The acid concentrate with citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
Standard Dialysate: Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. The acid concentrate without citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
|
Standard Dialysate Then Citrate Dialysate
Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a citrate acid concentrate dialysate for the second year of the study.
Citrate Dialysate: Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. When used, citrate is provided in the acid concentrate. The acid concentrate with citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
Standard Dialysate: Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. The acid concentrate without citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
|
|---|---|---|
|
First year of study
STARTED
|
29
|
25
|
|
First year of study
COMPLETED
|
17
|
17
|
|
First year of study
NOT COMPLETED
|
12
|
8
|
|
Second year of study
STARTED
|
17
|
17
|
|
Second year of study
COMPLETED
|
16
|
13
|
|
Second year of study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Citrate Dialysate Then Standard Dialysate
Participants receiving hemodialysis using a citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a non-citrate acid concentrate dialysate (standard dialysate) for the second year of the study.
Citrate Dialysate: Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. When used, citrate is provided in the acid concentrate. The acid concentrate with citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
Standard Dialysate: Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. The acid concentrate without citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
|
Standard Dialysate Then Citrate Dialysate
Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a citrate acid concentrate dialysate for the second year of the study.
Citrate Dialysate: Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. When used, citrate is provided in the acid concentrate. The acid concentrate with citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
Standard Dialysate: Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. The acid concentrate without citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
|
|---|---|---|
|
First year of study
Death
|
2
|
4
|
|
First year of study
Lost to Follow-up
|
5
|
2
|
|
First year of study
Physician Decision
|
3
|
1
|
|
First year of study
Protocol Violation
|
1
|
0
|
|
First year of study
Withdrawal by Subject
|
1
|
1
|
|
Second year of study
Death
|
1
|
1
|
|
Second year of study
Lost to Follow-up
|
0
|
2
|
|
Second year of study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effect of Citrate Dialysate on Vascular Calcification
Baseline characteristics by cohort
| Measure |
Citrate Dialysate Then Standard Dialysate
n=29 Participants
Participants receiving hemodialysis using a citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a non-citrate acid concentrate dialysate (standard dialysate) for the second year of the study.
|
Standard Dialysate Then Citrate Dialysate
n=25 Participants
Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a citrate acid concentrate dialysate for the second year of the study.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=54 Participants
|
18 Participants
n=60 Participants
|
40 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
14 Participants
n=114 Participants
|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 9.5 • n=54 Participants
|
59.8 years
STANDARD_DEVIATION 11.3 • n=60 Participants
|
58.0 years
STANDARD_DEVIATION 10.4 • n=114 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=54 Participants
|
25 Participants
n=60 Participants
|
54 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=54 Participants
|
25 Participants
n=60 Participants
|
54 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=54 Participants
|
25 Participants
n=60 Participants
|
54 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=54 Participants
|
25 Participants
n=60 Participants
|
54 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 3 measurements during 12 months of treatment for each study period (up to 24 months for both years of the study)Population: This analysis includes participants who completed both years of the study. One participant was excluded from due to the mammograms having inconsistent breast coverage resulting in the scans not being adequate for measurement of breast arterial calcification (BAC), providing a sample size of 28 participants for analysis.
Rate of progression of breast arterial calcification (BAC) is calculated by linear regression of 3 mammograms over one year in each treatment arm (Months 0, 6 and 12 versus Months 12, 18 and 24). Progression of calcification is quantified as the length of calcified artery segments per year, measured in millimeters. Slower progression of vascular calcification, indicated by lower values, is a desirable outcome.
Outcome measures
| Measure |
Citrate Dialysate
n=28 Participants
Participants receiving hemodialysis using a citrate acid concentrate dialysate during the first year of the study, or the second year of the study.
|
Standard Dialysate
n=28 Participants
Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, or the second year of the study.
|
|---|---|---|
|
Length of Calcified Artery Segments
|
47 millimeters (mm) per year
Interval 10.0 to 124.0
|
9 millimeters (mm) per year
Interval -4.0 to 34.0
|
SECONDARY outcome
Timeframe: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)Population: This analysis includes participants completing both years of the study. One participant was excluded from due to the mammograms having inconsistent breast coverage resulting in the scans not being adequate for measurement of BAC, providing a sample size of 28 participants for analysis. Post-dialysis serum iCa was not measured in one participant during the citrate arm. During the standard dialysate arm, pre-dialysis serum iCa was missing on one participant, post-dialysis iCa on two participants.
Blood samples were drawn to assess mineral metabolism prior to hemodialysis (HD) and after HD. The values are the mean milligrams (mg) of ionized calcium per deciliter (dL) of blood from two measurements during each study period.
Outcome measures
| Measure |
Citrate Dialysate
n=28 Participants
Participants receiving hemodialysis using a citrate acid concentrate dialysate during the first year of the study, or the second year of the study.
|
Standard Dialysate
n=27 Participants
Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, or the second year of the study.
|
|---|---|---|
|
Serum Ionized Calcium (iCa)
Pre-HD
|
4.8 mg/dL
Standard Error 0.07
|
4.8 mg/dL
Standard Error 0.10
|
|
Serum Ionized Calcium (iCa)
Post-HD
|
4.6 mg/dL
Standard Error 0.04
|
4.9 mg/dL
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)Population: This analysis includes participants completing both years of the study. One participant was excluded from due to the mammograms having inconsistent breast coverage resulting in the scans not being adequate for measurement of BAC, providing a sample size of 28 participants for analysis. Both pre-dialysis and post-dialysis serum Mg are missing for two participants during the standard dialysate arm.
Blood samples were drawn to assess mineral metabolism prior to and after hemodialysis (HD). The values are mean milligrams (mg) of magnesium per deciliter (dL) of blood from two measurements during each study period.
Outcome measures
| Measure |
Citrate Dialysate
n=28 Participants
Participants receiving hemodialysis using a citrate acid concentrate dialysate during the first year of the study, or the second year of the study.
|
Standard Dialysate
n=26 Participants
Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, or the second year of the study.
|
|---|---|---|
|
Serum Magnesium (Mg)
Post-HD
|
2.0 mg/dL
Standard Error 0.02
|
2.1 mg/dL
Standard Error 0.03
|
|
Serum Magnesium (Mg)
Pre-HD
|
2.3 mg/dL
Standard Error 0.04
|
2.4 mg/dL
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)Population: This analysis includes participants completing both years of the study. One participant was excluded from due to the mammograms having inconsistent breast coverage resulting in the scans not being adequate for measurement of BAC, providing a sample size of 28 participants for analysis. Plasma citrate was not measured in 3 participants who were at the furthest outlying dialysis center, due to logistical issues.
Blood samples were drawn to assess mineral metabolism prior to hemodialysis (HD) and after HD. The values are the mean from two measurements during each study period.
Outcome measures
| Measure |
Citrate Dialysate
n=25 Participants
Participants receiving hemodialysis using a citrate acid concentrate dialysate during the first year of the study, or the second year of the study.
|
Standard Dialysate
n=25 Participants
Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, or the second year of the study.
|
|---|---|---|
|
Plasma Citrate
Pre-HD
|
134 micrometer (uM)
Standard Error 9
|
130 micrometer (uM)
Standard Error 7
|
|
Plasma Citrate
Post-HD
|
383 micrometer (uM)
Standard Error 16
|
187 micrometer (uM)
Standard Error 20
|
Adverse Events
Citrate Dialysate
Standard Dialysate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place